Brussels, 08/01/2013 (Agence Europe) - On 3 January, Michèle Rivasi, the vice-chair of the Greens-EFA Group at the European Parliament, questioned the European Medicines Agency (EMA) on risks of veinous thrombosis complications from the third and fourth generation of contraceptive pills, in response to a complaint filed by France against the pharmaceutical group Bayer.
On 14 December, a young woman lodged a complaint against Bayer as she considered that the third generation pill that she was using, marketed by Bayer, was at the origin of her handicap that followed a CVA. Rivasi asked the EMA what the conditions were prior to the marketing of these contraceptives and she asked questions about the possible launch of an alert at European level in the case of a serious threat to health, as the new European legislation on pharmacovigilance now allows. “According to the national agency for medicine safety, France is the country that prescribes the third generation pill the most. This is all the more surprising as these third and fourth generation pills are much more expensive than the previous ones although they have a lower dosage. The alert was given in France but what is the situation in the other countries of the European Union?”, Rivasi asked (our translation). Considering that a real lack of information exists for doctors on the risks of these contraceptive pills, Rivasi asked the EMA how it intended to strengthen information for doctors and why it was not possible to quite simply withdraw the pills in question rather than formulate warnings. (IL/transl.fl)